olmesartan medoxomil, amlodipine and hydrochlorothiazide

Generic: olmesartan medoxomil, amlodipine and hydrochlorothiazide

Labeler: camber pharmaceuticals, inc.
NDC Directory HUMAN PRESCRIPTION DRUG ANDA Inactive Finished

Drug Facts

Product Profile

Brand Name olmesartan medoxomil, amlodipine and hydrochlorothiazide
Generic Name olmesartan medoxomil, amlodipine and hydrochlorothiazide
Labeler camber pharmaceuticals, inc.
Dosage Form TABLET, FILM COATED
Routes
ORAL
Active Ingredients

amlodipine besylate 5 mg/1, hydrochlorothiazide 25 mg/1, olmesartan medoxomil 40 mg/1

Manufacturer
Camber Pharmaceuticals, Inc.

Identifiers & Regulatory

Product NDC 31722-894
Product ID 31722-894_47b1c419-e608-66b1-e063-6394a90ae253
Product Type HUMAN PRESCRIPTION DRUG
Marketing Category ANDA
Application Number ANDA209242
Listing Expiration 2027-12-31
Marketing Start 2025-10-06

Pharmacologic Class

Established (EPC)
thiazide diuretic [epc]
Chemical Structure
thiazides [cs]
Physiologic Effect
increased diuresis [pe]

Normalized Code Variants

Searchable formats for this product NDC code

Digits Only 31722894
Hyphenated Format 31722-894

Supplemental Identifiers

RxCUI
999967 999986 999991 999996 1000001
UPC
0331722894906 0331722896306 0331722894302 0331722895309 0331722893305 0331722892902 0331722895903 0331722896900 0331722892308 0331722893909
UNII
0J48LPH2TH 864V2Q084H 6M97XTV3HD
NUI
N0000175359 N0000175419 M0471776

Packaging Origin

Original Packager
true

Resolved Product View

Precedence rule: structured NDC data is preferred, falling back to linked label metadata when unavailable. Source tags show the origin of each value.

Resolved Identity

Brand Name olmesartan medoxomil, amlodipine and hydrochlorothiazide (source: ndc)
Generic Name olmesartan medoxomil, amlodipine and hydrochlorothiazide (source: ndc)
Application Number ANDA209242 (source: ndc)
Routes
ORAL
source: ndc

Resolved Composition

Strengths
  • 5 mg/1
  • 25 mg/1
  • 40 mg/1
source: ndc
Packaging
  • 30 TABLET, FILM COATED in 1 BOTTLE (31722-894-30)
  • 10 BLISTER PACK in 1 CARTON (31722-894-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-894-31)
  • 90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90)
source: ndc

Packages (3)

31722-894-30 30 TABLET, FILM COATED in 1 BOTTLE (31722-894-30) 31722-894-32 10 BLISTER PACK in 1 CARTON (31722-894-32) / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-894-31) 31722-894-90 90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90)

Ingredients (3)

amlodipine besylate (5 mg/1) hydrochlorothiazide (25 mg/1) olmesartan medoxomil (40 mg/1)

Linked Drug Pages (1)

Olmesartan medoxomil, amlodipine and hydrochlorothiazide ndc-match (0.9)

Raw FDA Data

View complete raw FDA NDC JSON payload 
{"route": ["ORAL"], "spl_id": "47b1c419-e608-66b1-e063-6394a90ae253", "openfda": {"nui": ["N0000175359", "N0000175419", "M0471776"], "upc": ["0331722894906", "0331722896306", "0331722894302", "0331722895309", "0331722893305", "0331722892902", "0331722895903", "0331722896900", "0331722892308", "0331722893909"], "unii": ["0J48LPH2TH", "864V2Q084H", "6M97XTV3HD"], "rxcui": ["999967", "999986", "999991", "999996", "1000001"], "spl_set_id": ["45e975ff-07b1-411a-96ee-a011d1619b1e"], "pharm_class_cs": ["Thiazides [CS]"], "pharm_class_pe": ["Increased Diuresis [PE]"], "pharm_class_epc": ["Thiazide Diuretic [EPC]"], "manufacturer_name": ["Camber Pharmaceuticals, Inc."], "is_original_packager": [true]}, "finished": true, "packaging": [{"sample": false, "description": "30 TABLET, FILM COATED in 1 BOTTLE (31722-894-30)", "package_ndc": "31722-894-30", "marketing_start_date": "20251006"}, {"sample": false, "description": "10 BLISTER PACK in 1 CARTON (31722-894-32)  / 10 TABLET, FILM COATED in 1 BLISTER PACK (31722-894-31)", "package_ndc": "31722-894-32", "marketing_start_date": "20251006"}, {"sample": false, "description": "90 TABLET, FILM COATED in 1 BOTTLE (31722-894-90)", "package_ndc": "31722-894-90", "marketing_start_date": "20251006"}], "brand_name": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide", "product_id": "31722-894_47b1c419-e608-66b1-e063-6394a90ae253", "dosage_form": "TABLET, FILM COATED", "pharm_class": ["Angiotensin 2 Receptor Antagonists [MoA]", "Angiotensin 2 Receptor Blocker [EPC]", "Calcium Channel Antagonists [MoA]", "Calcium Channel Blocker [EPC]", "Cytochrome P450 3A Inhibitors [MoA]", "Dihydropyridine Calcium Channel Blocker [EPC]", "Dihydropyridines [CS]", "Increased Diuresis [PE]", "Thiazide Diuretic [EPC]", "Thiazides [CS]"], "product_ndc": "31722-894", "generic_name": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide", "labeler_name": "Camber Pharmaceuticals, Inc.", "product_type": "HUMAN PRESCRIPTION DRUG", "brand_name_base": "Olmesartan medoxomil, amlodipine and hydrochlorothiazide", "active_ingredients": [{"name": "AMLODIPINE BESYLATE", "strength": "5 mg/1"}, {"name": "HYDROCHLOROTHIAZIDE", "strength": "25 mg/1"}, {"name": "OLMESARTAN MEDOXOMIL", "strength": "40 mg/1"}], "application_number": "ANDA209242", "marketing_category": "ANDA", "marketing_start_date": "20251006", "listing_expiration_date": "20271231"}